Zurth, Christian http://orcid.org/0000-0002-0881-846X
Koskinen, Mikko
Fricke, Robert
Prien, Olaf
Korjamo, Timo
Graudenz, Kristina
Denner, Karsten
Bairlein, Michaela
von Bühler, Clemens-Jeremias
Wilkinson, Gary
Gieschen, Hille
Funding for this research was provided by:
Orion Corporation Orion Pharma
Bayer AG
Article History
First Online: 30 September 2019
Compliance with Ethical Standards
:
: This trial was supported by Orion Corporation Orion Pharma and Bayer AG.
: Christian Zurth, Robert Fricke, Olaf Prien, Kristina Graudenz, Karsten Denner, Michaela Bairlein, Clemens-Jeremias von Bühler, Gary Wilkinson and Hille Gieschen are employees of Bayer AG. Drs. Zurth, Prien, Denner, Wilkinson and Gieschen are also stockholders of Bayer AG. Mikko Koskinen and Timo Korjamo are employees and stockholders of Orion Corporation Orion Pharma.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committees and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The protocols were approved by the Ethics Committee of the State Medical Chamber of Berlin (NCT03048110 and NCT02671097) and the Ethics Committee of the State Medical Chamber of Baden-Württemberg (NCT03237416).
: Informed consent was obtained from all individual participants in the studies.
: Availability of the data underlying this publication will be determined according to Bayer’s commitment to the EFPIA/PhRMA “Principles for responsible clinical trial data sharing.” This pertains to the scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 1, 2014. Interested researchers can use ExternalRef removed to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study Sponsors section of the portal. Data access will be granted to anonymized patient-level data, protocols and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.